Device Recall Clearview Simplify

  • Model / Serial
    Kit lot number: PX018A Test device batch number: 682-024 Catalog Number: 6100KVC Expiration date: 3/2008
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, and Canada.
  • Product Description
    Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. || Product No. 61100KVC || 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide || 10 plastic pipettes || Wampole Laboratories || Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Inverness Medical Professional Diagnostics, 2 Research Way, Princeton NJ 08540-6628
  • Source
    USFDA